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LYTGOBI futibatinib 4 mg tablet blister pack, Taiho Pharma Oceania Pty Ltd, CON-1413
Product name
LYTGOBI futibatinib 4 mg tablet blister pack
Sponsor name
Taiho Pharma Oceania Pty Ltd
Batches
Batches released between 23 September 2025 and 31 July 2027.
Consent start
Consent no.
CON-1413
Duration
The consent is effective from 23 September 2025 until 31 July 2027.
Standard
Paragraph 14(a)(vii) and paragraph 14(a)(viii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because they have the Japanese labelled blister
strip, which does not include the batch number prefix in front of the batch
number, and the expiry date and expiry date prefix are not included.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter will be supplied with each affected
batch describing the issue.
2. The blister strips will be packed into a carton with the Australian approved
label.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines